COVID-19 – SG016 Clinical Trial Data Readout

On 20 July 2020, Synairgen announced positive results from its Phase II double-blind placebo-controlled trial, called SG016, in hospitalised COVID-19 patients. The primary endpoint was the change in condition assessed using the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period. More detailed results of primary endpoint analyses were disclosed in Synairgen’s 2020 Interim Results on 29 September 2020, which can be read here.

 Key findings included:

 The odds of improvement across the entire OSCI scale were more than two-fold greater in the SNG001 group than the placebo group on day 16 in both the ITT (Intention-To-Treat) population (OR 2.32; p=0.033) and the PP (Per Protocol) population (OR 2.80; p=0.017)

 There was a trend towards reduced odds of progression to severe disease (requiring non-invasive ventilation, high-flow oxygen, intubation and mechanical ventilation) or death in the ITT population (72% reduction; p=0.064) that became significant in the PP population (82% reduction; p=0.041)

 Patients who received SNG001 were more than twice as likely to recover (defined as ‘no limitation of activities’ or ‘no clinical or virological evidence of infection’) over the course of the treatment period compared to those receiving placebo in both the ITT population (HR 2.19; p=0.017) and the PP population (HR 2.29; p=0.033)

 Over the treatment period, patient-reported Breathlessness Cough and Sputum Scale (BCSS) and in particular breathlessness scores were markedly reduced in patients who received SNG001 compared to those receiving placebo (p=0.026 for BCSS and p=0.007 for breathlessness)

SG016 Home Study Trial

For patients interested in participating in the SG016 home trial, please see the following link for more information:

www.covidtrialathome.com